1. Field of the Invention
The present invention relates generally to vaginal douches and, more particularly, to methods of treating abnormal biological conditions arising in and/or affecting the vagina.
2. Brief Discussion of the Related Art
In the area of female personal hygiene and gynecological health, vaginal douches have been proposed for reducing vaginal odors. Conventional vaginal douches typically involve the application of a stream of douching fluid through a vaginal douche applicator and into the vaginal canal of the user. Water alone as a douching fluid is not effective at significantly alleviating vaginal odors when used in conjunction with vaginal douche applicators that do not have a stainless steel external surface. Since it is most typical for vaginal douche applicators to be made of inexpensive disposable materials, such as plastic, conventional vaginal douches usually include various commercial douching agents or substances, such as cleansing and/or disinfecting agents and/or perfumes, to be mixed with water by the user to obtain a douching fluid or supplied to the user as a prepared douching fluid. However, commercial douching agents or substances tend not to be effective in alleviating some vaginal odors or may serve merely to temporarily mask vaginal odors. Even when commercial douching agents or substances are effective in alleviating vaginal odors, the vaginal odors may return shortly after douching.
Another problem associated with many conventional vaginal douches is that the douching agents or substances may cause irritation in some users and/or tend to alter the normal pH (acid/alkaline) or chemical balance of the vaginal canal. When the vaginal canal becomes irritated and/or has its normal pH (acid/alkaline) or chemical balance disturbed or altered, an increased risk is presented for vaginitis, including yeast, bacterial vaginosis and other infections. Vinegar has been proposed as a natural douching agent or substance which, when mixed with water in the proper proportion, presents a douching fluid that closely mimics the normal pH of the vaginal canal. However, douching fluids consisting of vinegar and water tend not to be effective against vaginal odors for any meaningful length of time.
The issue of vaginal odor alleviation is addressed in U.S. Pat. No. 6,290,365 B1 to Abbott et al, the entire disclosure of which is incorporated herein by reference, disclosing the alleviation of vaginal odors by contacting vaginal tissue with a stainless steel surface of a vaginal douche applicator in the presence of water.
A further problem associated with many conventional vaginal douches is that the vaginal douche applicators discharge douching fluid directly at and/or toward the cervix with sufficient force or pressure so that douching fluid may enter the cervical canal. When this occurs, vaginal debris such as bacteria and other harmful or undesirable organisms carried by the douching fluid may pass through the cervix and enter the uterine cavity, potentially causing pelvic inflammatory disease. Where douching fluid is not discharged toward the cervix and the upper portion of the vaginal canal, however, odors will not be eliminated or will quickly return since the cervix as well as the vaginal tissue are responsible for odors. Hence, failure to wash off the cervix and the upper portion, or fornix, of the vaginal canal will yield an incomplete douching. An additional problem of many conventional vaginal douches relates to the inadequacy of the vaginal douche applicators in maintaining an unobstructed gravity flow of douching fluid from the vaginal canal. Since the vaginal canal is normally collapsed or contracted, it has a tendency to clamp down on a vaginal douche applicator inserted therein. Accordingly, douching fluid containing vaginal debris may be prevented from exiting the vaginal canal and may collect and become trapped in the vaginal canal thereby allowing bacteria and other harmful organisms, including those responsible for sexually transmitted diseases, to remain in and move higher in the vaginal canal after douching. During douching, trapped douching fluid may build up in the vaginal canal with a sufficient pressure head that the douching fluid is detrimentally forced into and/or through the cervical canal. Many conventional vaginal douches are also problematic for their failure to limit, regulate or control the flow of douching fluid into the vaginal douche applicators such that the douching fluid is discharged from the applicators at pressures high enough to force the douching fluid into the cervix. Other drawbacks to many conventional vaginal douches are that the vaginal douche applicators are not designed for reuse and are actually unsuitable for reuse due to the difficulties involved in maintaining cleanliness for repeated use.
Normal, balanced vaginal environments are characterized in part by trace numbers of yeast cells, trace numbers of coccoid bacteria called Gardnerella vaginalis and a preponderance of lactobacillus bacteria. Vaginal environments that are disturbed or unbalanced include those having an overgrowth of coccoid bacteria. Coccoid overgrowth is associated with an abnormal biological condition known as bacterial vaginosis, characterized by various symptoms which may be present constantly or may appear intermittently. One out of four women may be infected with bacterial vaginosis, yet 50% of infected women may be asymptomatic. Inflammation associated with bacterial vaginosis may extend to the fallopian tubes and endometrium. Also, the production of amines, such as putrescine and cadaverine, may have a carcinogenic effect, with there being a statistical association between coccoid overabundance and cervicitis and epithelial changes. The effects of bacterial vaginosis are believed to synergize with human immunodeficiency virus (HIV) and human papilloma virus (HPV). In the case of HIV, the presence of bacterial vaginosis may cause increased numbers of virus secreting cells and/or may enhance cell binding by the virus, thereby resulting in an increased risk for HIV transmission. In the case of HPV, the presence of bacterial vaginosis may result in the survival of oncogenic cell mutations related to cervical carcinoma, and research indicates bacterial vaginosis to be a precursor to cervical cancer. Accordingly, the presence of bacterial vaginosis has been linked to increased incidences of cervical cancer and sexually transmitted diseases, and may enable harmful viruses to infect healthy tissue. An excess of yeast cells may lead to problems, one such problem being fungal proliferation or yeast infections characterized by itching, burning and/or abnormal discharge. Unfortunately, health care providers and conventional gynecological tests such as pap smears do not routinely screen for bacterial vaginosis and yeast infections.
A relationship has been established between bacterial vaginosis and recent coitus. Since semen is alkaline, the normal pH of the vaginal canal increases significantly after coitus and changes from mildly acidic to a more alkaline level such that the normal pH (acid/alkaline) of the vaginal environment is unbalanced or disturbed. This higher pH promotes a rapid increase in coccoid production and may result in coccoid overgrowth leading to bacterial vaginosis and its various adverse consequences. Accordingly, post-coital vaginal douching using conventional plastic applicators and commercial douching agents or water to wash away semen and/or coccoid bacteria may have some limited benefit in preventing bacterial vaginosis and/or counteracting already existing bacterial vaginosis but has not been shown to reliably prevent and eliminate bacterial vaginosis. Because of the various problems and limited effectiveness of most conventional vaginal douches, vaginal douching has not been widely adopted and used, particularly in the United States, as a preventative and/or treatment for bacterial vaginosis.
A healthy vagina is moderately acidic, with a normal pH in the range of about 3.5 to 4.5. Where vaginal pH exceeds about 4.5, the vaginal environment may be considered abnormal and is conducive to the development of bacterial vaginosis. On the other hand, a vaginal pH below about 3.5 presents an abnormal environment that is favorable to the development of fungal infections. Normal vaginal flora and pH may be disrupted by many commercial douching agents which tend to kill off beneficial lactobacilli and allow overgrowth of harmful bacteria, by poor hygiene encouraging the overgrowth of harmful bacteria, by increased pH levels resulting from the presence of semen, by wearing tight and/or damp clothing and/or by incorrectly treating a vaginal infection with the wrong medication.
Conventional treatments for bacterial vaginosis include topical and oral antibiotics which possess adverse side effects and promote the development of drug-resistant bacteria. Only about 50% of bacterial vaginosis cases are eliminated in response to conventional treatments and even successfully treated cases tend to recur. It has been shown that about 30% of bacterial vaginosis cases recur after three months and about 80% recur after nine months following conventional antibiotic treatments. Furthermore, conventional antibiotic treatments for bacterial vaginosis may leave patients at increased risk for fungal infections by over-correcting the vaginal environment. Various over-the-counter anti-fungal products are available to treat fungal infections of the vaginal canal. However, users of conventional anti-fungal products may have their vaginal pH increased too far and may be at increased risk for bacterial infections.
Each type of vaginal infection currently requires its own specific treatment. Unfortunately, the various symptoms of vaginal infection are not recognized by most women, and frequently the infection is not accurately diagnosed by doctors. Too often, healthcare providers and patients incorrectly assume the presence of a yeast infection and seek relief from over-the-counter anti-yeast medication. However, a recent study of 1000 American women who purchased anti-yeast medication showed that only 28% actually had a yeast infection, while the remaining 72% of women had other vaginitis. Using an incorrect medication can often worsen the actual condition. Introducing an anti-yeast medication in the absence of a yeast infection may result in abnormal vaginal flora after only one day. After five days of using the medication, the beneficial lactobacilli may be almost totally eliminated, which makes the underlying bacterial infection even more severe. Diagnosis and treatment of various abnormal biological conditions arising in or affecting the vagina is made more complicated by the fact that the conditions may be asymptomatic.
The treatment of abnormal biological conditions in aqueous environments like the vagina is made more difficult where the organisms responsible for the abnormal conditions are present as biofilm. Biofilm forms when bacteria adhere to a surface in an aqueous environment and begin to excrete a slimy substance that can anchor them to the surface. A biofilm may be formed by a single bacterial species, but more often includes many species of bacteria as well as fungi, algae, protozoa, debris and corrosion products. Once anchored to a surface, biofilm microorganisms may initiate a variety of detrimental reactions. Biofilms are implicated in a significant proportion of human bacterial infections.
Biofilm bacterial behavior is much more complex than planktonic or suspended cell behavior due to colonization of the biofilm organisms. Unlike suspended cells, biofilm organisms live in and populate communities. Recent studies have revealed significant differences in the level of expression of genes involved in nutrient cycling among members of a single species bacterial population exposed to the same apparent conditions. Within these populations, there appears to be a “division of labor” whereby some cells utilize available energy to turn on metabolic pathways that effect partial degradation of dead particulate matter while other cells of the same population utilize the degradation products to produce new cells. A bacterium which attaches to a surface thusly activates a different set of genes which transform it into a significantly different organism than the same bacterium in suspension. Most bacterial on the behavior of suspended cells are less effective on biofilm cells. For example, antibiotic doses which kill suspended cells in humans may need to be increased to prohibitively toxic levels in order to kill biofilm cells, and biofilms have thusly contributed to the problem of drug-resistance. Disinfection rates for biofilm cells are far below the disinfection rates for planktonic cells killed by antimicrobials.
Conventional douching with plastic applicators and commercial douching agents or water may benefit vaginal environments that are already undesirably altered or disturbed, but the benefits derived are very limited and may be outweighed by the many disadvantages of conventional douching. Douching fluids including water, vinegar and/or commercial douching agents used with conventional plastic douche applicators fail to properly normalize and stabilize disturbed vaginal environments and either undercorrect or overcorrect for vaginal disturbances. Conventional douching may temporarily improve one aspect of the vaginal environment while creating imbalances or disturbances in other aspects thereof. The benefits derived from conventional douching are very short-lived, yet conventional douching performed too frequently is potentially harmful in many respects and may actually greatly exacerbate vaginal disturbances. Indeed, the benefits provided by conventional douching generally amount to merely masking the symptoms of vaginal disturbances without a clinically significant correction of the underlying causes of abnormalities. Accordingly, conventional douching is unsuitable as a treatment and/or preventative for bacterial vaginosis and yeast infections much less other abnormal biological conditions arising in or affecting the vagina.
It is evident from the foregoing that there is a need for more effective treatments for abnormal biological conditions arising in and/or affecting the vagina. There is also a need for a method of treating abnormal biological conditions arising in and/or affecting the vagina wherein the method is capable of treating various different abnormal biological conditions. Another need exists for safe, non-pharmacological treatments for biofilms and other abnormal biological conditions arising in and/or affecting the vagina. A further need exists for methods of treating abnormal biological conditions arising in and/or affecting the vagina where the treatment itself does not contribute to abnormal biological conditions or disturbances.